U.S. patent application number 15/812500 was filed with the patent office on 2018-05-31 for robotic knee testing (rkt) device having decoupled drive capability and systems and methods providing the same.
The applicant listed for this patent is ERMI, Inc.. Invention is credited to Thomas P. Branch, Nathaniel K. DeJarnette, Edward Dittmar, Thomas Christopher Madden, Timothy Shary, Shaun Kevin Stinton.
Application Number | 20180146891 15/812500 |
Document ID | / |
Family ID | 49322698 |
Filed Date | 2018-05-31 |
United States Patent
Application |
20180146891 |
Kind Code |
A1 |
Branch; Thomas P. ; et
al. |
May 31, 2018 |
Robotic Knee Testing (RKT) Device Having Decoupled Drive Capability
and Systems and Methods Providing The Same
Abstract
Various limb manipulation and evaluation devices are provided.
The devices generally include three drives, namely a first drive
configured to manipulate a first bone relative to a second bone in
a first direction, a second drive configured to manipulate the
first bone relative to the second bone in a second direction, a
third drive configured to manipulate the first bone relative to the
second bone in a second direction. The three directions are
different relative to each other and in some embodiments represent
three distinct axes. The devices are further configured such that
at least one of the drives is mutually decoupled relative to at
least one other drive, such that operation of the one drive does
not affect the position or movement of the another drive. One or
multiple of the drives may be decoupled. A corresponding method of
operating such decoupled drives is also provided.
Inventors: |
Branch; Thomas P.; (Atlanta,
GA) ; Stinton; Shaun Kevin; (Chamblee, GA) ;
Madden; Thomas Christopher; (Atlanta, GA) ; Dittmar;
Edward; (Marietta, GA) ; DeJarnette; Nathaniel
K.; (Lilburn, GA) ; Shary; Timothy; (Atlanta,
GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ERMI, Inc. |
Atlanta |
GA |
US |
|
|
Family ID: |
49322698 |
Appl. No.: |
15/812500 |
Filed: |
November 14, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14029780 |
Sep 17, 2013 |
9814411 |
|
|
15812500 |
|
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|
61702105 |
Sep 17, 2012 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/1121 20130101;
A61B 5/4585 20130101; A61B 5/702 20130101 |
International
Class: |
A61B 5/11 20060101
A61B005/11; A61B 5/00 20060101 A61B005/00 |
Claims
1-23. (canceled)
24. A limb manipulation and evaluation device comprising: a frame;
a first drive supported by the frame and configured to manipulate a
first bone relative to a second bone in a first direction about a
first axis; a second drive supported by the frame and configured to
manipulate said first bone relative to said second bone in a second
direction about a second axis; and a third drive supported by the
frame and configured to manipulate said first bone relative to said
second bone for movement of the first bone in a third direction,
wherein: said first, second, and third directions are different
directions, and at least one drive of the first, second, and third
drives is mutually decoupled relative to another drive of the
first, second, and third drives, such that operation of said one
drive does not affect position of said another drive relative to
the frame, and such that operation of said another drive does not
affect position of said one drive.
25. The limb manipulation and evaluation device of claim 24,
wherein the first, second, and third directions are orthogonal.
26. The limb manipulation and evaluation device of claim 24,
wherein the first axis is distal to a foot connected to the first
bone.
27. The limb manipulation and evaluation device of claim 24,
wherein the first and second drives are distal to a foot connected
to the first bone.
28. The limb manipulation and evaluation device of claim 24,
wherein the third drive is configured to provide torque about a
third axis to move the tibia in the third direction.
29. The limb manipulation and evaluation device of claim 28,
wherein the third axis is distal to a foot connected to the first
bone.
30. A limb manipulation and evaluation device comprising: a frame;
a first drive supported by the frame and configured to manipulate a
first bone relative to a second bone in a first direction, the
first bone being connected to the second bone at a joint; a second
drive supported by the frame and configured to manipulate said
first bone relative to said second bone in a second direction; and
a third drive supported by the frame and configured to manipulate
said first bone relative to said second bone for movement of the
first bone in a third direction, wherein: said first, second, and
third directions are orthogonal directions, and at least one drive
of the first, second, and third drives is mutually decoupled
relative to another drive of the first, second, and third drives,
such that operation of said one drive does not affect position of
said another drive relative to the frame, and such that operation
of said another drive does not affect position of said one
drive.
31. The limb manipulation and evaluation device of claim 30,
wherein the first drive is distal to a foot connected to the first
bone.
32. The limb manipulation and evaluation device of claim 30,
wherein the first and second drives are distal to a foot connected
to the first bone.
33. The limb manipulation and evaluation device of claim 30,
wherein the third drive is configured to provide torque about a
third axis to move the tibia in the third direction.
34. The limb manipulation and evaluation device of claim 30,
wherein the third drive is distal to a foot connected to the first
bone.
35. A limb manipulation and evaluation device comprising: a frame;
a first drive supported by the frame and configured to manipulate
tibia relative to a femur in a first direction; a second drive
supported by the frame and configured to manipulate said tibia
relative to said femur in a second direction; and a third drive
supported by the frame and configured to manipulate said tibia
relative to said femur in a third direction, wherein: said first,
second, and third directions are different directions, and at least
one drive of the first, second, and third drives is mutually
decoupled relative to another drive of the first, second, and third
drives, such that operation of said one drive does not affect
position of said another drive relative to the frame, and such that
operation of said another drive does not affect position of said
one drive.
36. The limb manipulation and evaluation device of claim 35,
wherein the first, second, and third directions are orthogonal.
37. The limb manipulation and evaluation device of claim 35,
wherein the first drive is distal to a foot connected to the
tibia.
38. The limb manipulation and evaluation device of claim 35,
wherein the first and second drives are distal to a foot connected
to the tibia.
39. The limb manipulation and evaluation device of claim 35,
wherein the third direction is anterior-posterior translation.
40. The limb manipulation and evaluation device of claim 39,
wherein the third drive is configured to provide torque about an
axis to move the tibia in the anterior-posterior direction.
41. The limb manipulation and evaluation device of claim 39,
wherein the third drive is distal to a foot connected to the
tibia.
42. The limb manipulation and evaluation device of claim 35,
wherein the first direction is internal-external rotation of the
tibia.
43. The limb manipulation and evaluation device of claim 35,
wherein the second direction is varus-valgus rotation of the tibia.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 14/029,780, filed Sep. 17, 2013, and entitled "Robotic Knee
Testing (RKT) Device Having Decoupled Drive Capability and Systems
and Methods Providing The Same," which, in turn, claims priority to
and the benefit of U.S. Provisional Application Ser. No.
61/702,105, filed Sep. 17, 2012, the contents of which are hereby
incorporated herein by reference in their entirety.
BACKGROUND
Field of Invention
[0002] This generally relates to three-dimensional joint motion
evaluation using computer-controlled torque application via, for
example, a robotic knee testing device (an "RKT" device) which
controls the direction, rate, and magnitude of forces applied in at
least three directions. The respective forces are configured to
evaluate "IE" (internal-external) movement about a Z-axis of
rotation distal to the foot, varus-valgus conditions about a Y-axis
of rotation distal to the foot, and "AP" (anterior-posterior)
movement of the tibia through a proximal tibia contact arm which
rotates about a X-axis of rotation distal to the foot.
Description of Related Art
[0003] The knee is composed of the femur or thigh bone, the tibia
or shin bone and the patella or knee cap. They are connected by
fibrous structures called ligaments which allow a certain amount of
`joint play` or motion to exist between the bone structures. When
this `joint play` is increased or decreased, an abnormal or
pathological condition exists in the knee. Attempts have been made
in the past to quantify this increase or decrease in `joint play`
of the knee with limited success.
[0004] An injury to the knee can cause damage to one or more of the
structures of the knee causing an increase in the `joint play` or
motion of the knee. This increase in `joint play` can create the
sensation to the patient that the knee is slipping or `coming out
of joint`. Commonly, this sensation described by the patient is
referred to as the feeling of `joint instability`. The ability of
the two bones to actually `come out of joint` is related to the
length of the fibrous structures or ligaments which connect the two
bones together as well as the shape and size of the two bones (or
three). The ability of the bones to `come out of joint` or become
unstable is related to the amount of stretch or the amount of
increased lengthening of each ligament, the number of ligaments
involved, and damage to other support structures of the knee such
as the bone itself and the menisci. Accurate measurement of this
increased ligament length can be critical to restore the knee to as
close to its original functional and anatomical state as
possible.
[0005] Currently, there are only manual tests used by clinicians to
aid in the diagnosis of ligament damage resulting in a change in
joint play. As an example, there are three manual tests to evaluate
the increased joint play associated with an ACL tear--the Lachman's
test, the Pivot Shift test and the Anterior Drawer Test. All of
these tests suffer from the clinician's subjective evaluation of
both the extent of the ligament lengthening and the change in the
compliance or stretchiness of the ligament.
[0006] The Lachman's test is performed by laying the patient in a
supine position and bending the knee at approximately 20 to 30
degrees. The clinician places a hand on the patient's upper thigh
and his other hand below the upper part of the patient's calf.
Pressure is applied under the patient's calf and down on the
patient's thigh such that there is a translation between the femur
and the tibia.
[0007] Similar to the Lachman's test, the pivot shift test begins
by positioning the patient on his back. The knee is placed in full
extension (x-axis rotation) and a valgus (y-axis rotation) force
and an internal rotation (z-axis rotation) force is applied to the
knee to allow the lateral tibia to slip anteriorly from underneath
the lateral femoral condyle as the knee is flexed (x-rotation) the
tibia is allowed to slip suddenly back underneath the femoral
condyle. The clinician feels for an abnormal external rotation
(z-axis rotation) and posterior translation (y-axis translation) of
the tibia with respect to the femur. This shift is felt to
represent the relative increased translation (y-axis translation)
of the lateral side of the knee with respect to the increased
translation (y-axis translation) of the medial side of the knee.
Furthermore, the point of sudden shift represents the point at
which the tibia bone slides from in front of the radius of
curvature of the curved end of the femur back to its normal
position under the femoral condyle. The clinician subjectively
rates the pivot shift as Grade I, Grade II or Grade III depending
upon the degree of rotational and translational shift felt during
the test. This test is difficult to perform, difficult to teach and
difficult to quantify.
[0008] Finally, the anterior drawer test is performed with the
patient lying on his back and his knee bent 90 degrees. With the
patient's foot supported by a table or chair, the clinician applies
pressure to the knee using her thumbs. This test is graded based on
the amount or extent of anterior translation of the tibia with
respect to the femur. Grade I has 0 to 5 mm of anterior translation
Grade II has 6 to 10 mm of anterior translation, and Grade III has
11 to 15 mm of anterior translation.
[0009] To diagnose an injured ACL using the described tests, the
clinician must determine whether the knee feels "abnormal." Thus,
the accuracy of an ACL injury diagnosis using currently known tests
depends on the skill and experience of the clinician. A
misdiagnosis can lead to unnecessary delay in treatment, thereby
placing the patient at increased risk for further damage to the
knee.
[0010] There are manual tests for the LCL, MCL and the PCL. Each
manual test relies on grading the ligament lengthening based upon
relative increase in joint play into three categories. There is no
effort to grade the compliance of the ligament; however, the expert
clinician will describe the ligament in terms of its `feel`. The
more ligaments and structures that are damaged; the more complex it
becomes to perform a manual knee examination with accuracy.
[0011] There have been multiple attempts in the past to instrument
the knee and quantify or measure the change in the structure of the
knee after ligament damage. Several devices have attempted to
accurately quantify the extent or relative displacement and
compliance of a ligament in the knee. One of these devices is The
KT-1000 and the KT-2000 Medmetric.RTM., which measures the
anterior-posterior translation of the tibia with respect to the
femur along the y-axis, but disadvantageously attach to the tibia.
These devices attempt to quantify the findings found when the
clinician uses the Lachman's test and the Anterior Drawer Test.
Force is applied to a handle on the device which measures force and
signals to the clinician the amount of force with a low pitched
sound for a 15 pound force and a higher pitched sound for a 20
pound force. This force pulls anteriorly along the y-axis through a
strap that wraps underneath the calf. The measurement of the
translation uses a technique measuring the relative motion of a pad
on the anterior tibia with respect to a pad placed on the patella.
This device does not measure relative displacement or compliance in
any of the other degrees of freedom previously described in the
knee. Furthermore, the quantified results of the KT-1000 or KT-2000
have not been correlated with patient satisfaction whereas the
subjective Pivot Shift test has been correlated with patient
satisfaction. Other devices such as the Stryker KLT, the Rolimeter,
and the KSS system use similar mechanisms to attempt to quantify
the normal amount of `joint play` or motion between the femur and
tibia, along with any increased `joint play` or motion which is
associated with ligament lengthening and damage.
[0012] Many non-invasive systems utilize sensors or markers that
are attached to the skin, including but not limited to
optoelectronic, ultrasonic, and electromagnetic motion analysis
systems. These skin sensors or markers are merely representations
of location of the underlying bones; however, many published
reports have documented the measurement error related to skin
artifact with this system. In order to avoid the inaccuracies
associated with skin artifact, medical imaging systems may be
utilized in order to precisely determine the position/location of
the bones accurately.
[0013] Surgeons manually examine the joint for altered play;
however, due to the variability in size of the patient, size and
experience of the surgeon, and the subtlety of injury, consistent
and reproducible reports of joint play between surgeons is not
possible. The need that must be met is to provide a controlled
application of torque during joint examination, with the magnitude,
direction, and rate of torque application being controlled. Many
reports have documented that, whether performed by hand or with
manual arthrometers, the manual application of torque varies
between clinicians, thus creating inconsistencies in the
examination of joint play.
[0014] Accordingly, there is a need for an accurate, objective,
reliable and reproducible measure of the impact of damage to the
ACL as well as other ligaments and structures in the knee or
combination of ligaments and other structures in the knee that can
be used in the clinical setting on patients. For example, since an
injury to the ACL produces both an increase in anterior translation
(y-axis translation) and rotation (z-axis rotation), an objective
measure of these changes would both aid in the diagnosis of the
injury as well as verify its restoration after ligament
reconstruction surgery. Additionally, measurement of displacement
and compliance around different degrees of freedom in the knee
would help objectively describe the individual and complex changes
to `joint play` that occurs in an injured knee with structural
damage. A need exists for systems and methods that can provide
accurate, reproducible and objective data on the changes in `joint
play` or motion that occurs with an injured knee compared to their
healthy knee and to the population as a whole such that the
clinician can achieve patient satisfaction with focused,
biomechanical and proven surgical interventions specific to that
injury and for that knee across the entire population of damaged
knees.
[0015] Needs also exist for systems and methods, and devices which
accommodate variances of patient body structure; it may well be
understood that each human body is different and may require
particular attention when being treated and/or analyzed; this may
be particularly evident in the case of abnormalities of bones,
tendons, joints, etc., due to injury or the like. Needs also exists
for systems and methods, and devices that can provide the type of
accurate, reproducible and objective data described above without
inherently and/or indirectly adversely impacting the accuracy,
reproducibility, and/or objectiveness of the tests and measured
data therein.
SUMMARY
[0016] Generally described, the present invention to provide
apparatuses and methods for evaluating the performance of joints
and their associated elements, as described elsewhere herein.
[0017] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a first bone
relative to a second bone in a first direction; a second drive
configured to manipulate the first bone relative to the second bone
in a second direction; and a third drive configured to manipulate
the first bone relative to the second bone in a second direction.
The first, second, and third directions are different relative to
each other, and at least one of the drives is mutually decoupled
relative to another drive, such that operation of the one drive
does not affect the position or movement of the another drive.
[0018] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a first bone
relative to a second bone about a first axis; a second drive
configured to manipulate the first bone relative to the second bone
about a second axis; and a third drive configured to manipulate the
first bone relative to the second bone about a third axis, wherein:
the first, second, and third axes are each oriented at an angle
relative to each other, and at least one of the drives is mutually
decoupled relative to another of the drives, such that operation of
the one drive does not affect the rotational axis of the another of
the drives.
[0019] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a first bone
relative to a second bone about a first axis, a second drive
configured to manipulate the first bone relative to the second bone
about a second axis, and a third drive configured to manipulate the
first bone relative to the second bone about a third axis, wherein:
the first, second, and third axes are each oriented at an angle
relative to each other, and at least two of the drives are
decoupled relative to a third drive, such that operation of either
of the two drives does not affect the rotational axis of the third
drive.
[0020] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a first bone
relative to a second bone about a first axis, a second drive
configured to manipulate the first bone relative to the second bone
about a second axis, and a third drive configured to manipulate the
first bone relative to the second bone about a third axis, wherein:
the first, second, and third axes are each oriented at an angle
relative to each other, and at least one of the drives is mutually
decoupled relative to the other two drives, such that operation of
the at least one drive does not affect the rotational axis of the
other two drives.
[0021] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a tibia relative
to a femur about a first axis, the first drive providing internal
and external rotation of the tibia relative to the femur; a second
drive configured to manipulate the tibia relative to the femur
about a second axis, the second drive providing anterior-posterior
movement of the tibia relative to the femur, and a third drive
configured to manipulate the tibia relative to a femur about a
third axis, the third drive providing valgus-varus movement of the
tibia relative to the femur, wherein: the first, second, and third
axes are each oriented at an angle relative to each other; the
first drive is decoupled from the second drive; and the first and
second drives are coupled with the third drive.
[0022] According to various embodiments a limb manipulation and
evaluation device including three drives is provided. The device
comprises: a first drive configured to manipulate a tibia relative
to a femur about a first axis, the first drive providing internal
and external rotation of the tibia relative to the femur; a second
drive configured to manipulate the tibia relative to the femur
about a second axis, the second drive providing anterior-posterior
movement of the tibia relative to the femur, and a third drive
configured to manipulate the tibia relative to a femur about a
third axis, the third drive providing valgus-varus movement of the
tibia relative to the femur, wherein: the first, second, and third
axes are each oriented at an angle relative to each other; the
first drive is coupled to the third drive; the second drive is
decoupled from the first and third drives; and the third drive is
decoupled from the first and second drives.
[0023] According to various embodiments a method of using three
drives to manipulate a first bone relative to a second bone is
provided. The method comprises the steps of: operating a first
drive configured to manipulate the first bone relative to the
second bone about a first axis; operating a second drive configured
to manipulate the first bone relative to the second bone about a
second axis; and operating a third drive configured to manipulate
the first bone relative to the second bone about a third axis,
wherein: the first, second, and third axes are each oriented at an
angle relative to each other, and the operation of at least one of
the drives is mutually decoupled relative to another of the drives,
such that the operation of the one drive does not affect the
rotational axis of the another of the drives.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Having thus described the invention in general terms,
reference will now be made to the accompanying drawings, which are
not necessarily to scale. In the drawings:
[0025] FIG. 1 is a perspective view of the overall device 10,
including two tibia positioning assemblies 1000 according to
various embodiments;
[0026] FIG. 2 is a view of a portion of FIG. 1, and in particular
illustrates a perspective view of the two tibia positioning
assemblies 1000 according to various embodiments;
[0027] FIG. 3 is an isolated view of one of the two tibia
positioning assemblies 1000 according to various embodiments;
[0028] FIG. 4 is an exploded view of the various elements of the
tibia positioning assembly 1000 of FIG. 3 according to various
embodiments;
[0029] FIG. 5 is a view of the tibia positioning assembly 1000 of
FIG. 3, but from an alternative facing perspective relative to that
of FIG. 3, illustrating exemplary axes X, Y, and Z of rotation,
along with calf bias assembly 1500 according to various
embodiments;
[0030] FIG. 6 is yet another view of the tibia positioning assembly
1000 of FIGS. 3 and 5, also illustrating an exemplary foot plate
assembly 1300 according to various embodiments;
[0031] FIG. 7 is an exploded view of the various element of a
sliding frame assembly 1100 and a "Y" axis drive assembly 2100 of
the tibia positioning assembly 1000 of FIG. 3 according to various
embodiments;
[0032] FIG. 8 is a top plan view of the tibia positioning assembly
1000 of FIG. 3, in an exemplary "right leg" configuration according
to various embodiments;
[0033] FIG. 9 is a side view of the tibia positioning assembly 1000
of FIG. 8 according to various embodiments;
[0034] FIGS. 10 and 11 illustrate two sequential steps of movement
of the device during operation of a "X" axis drive assembly 2000
according to various embodiments;
[0035] FIG. 12 illustrates a view along the "Z" axis of the tibia
positioning assembly 1000 of FIG. 3 according to various
embodiments, further illustrating exemplary X, Y, and Z axis drive
assemblies 2000, 2100, and 2200 (note that the illustrated "Z" axis
extends positive perpendicular to the foot plate extending distal
to the foot plate, the illustrated "Y" axis extends positive
straight up from "Z" axis and away from floor/ground, and the
illustrated "X" axis is parallel to the bottom of the foot plate
and is also parallel to the floor/ground according to various
embodiments so as to provide three mutually orthogonal axes);
[0036] FIG. 13 is an alternate configuration according to various
embodiments, illustrating the use of exemplary spherical elements
3001, 3002 for manipulating the lower leg of a patient (shown in
dotted line) about centers of the spheres, wherein sphere 3001 is
driven by an exemplary roller and drive assembly 3001A;
[0037] FIG. 14 is another alternate configuration illustrating the
use of an exemplary spherical element 3003 according to various
embodiments, with a center of rotation C3 located even further
distal to the foot and an exemplary calf bias member (aka extender
bar); and
[0038] FIG. 15 is yet another alternate configuration including a
spherical cage 4000 comprised of a plurality of cage bars 4005
according to various embodiments.
[0039] FIG. 16 shows an alternate configuration for the L Bracket
1220, in that L Bracket 1220, which supports the Z Drive motor, can
if desired slide along the Z axis relative to pivoting plate
assembly 1200 in order to accommodate "pistoning" of foot in varus
valgus procedure, allowing for the foot to move in a more natural
arc during varus-valgus testing. The foot plate and motor all move
together.
[0040] FIG. 17 is a side illustrative view of a leg testing
apparatus 5000, in combination with an exemplary CT scanner 4900,
and a patient's body support apparatus 4950. The three devices are
configured to be typically situated atop an unnumbered supporting
surface. Also shown is an exemplary patient, including a patient
upper body 4951, patient lower leg 4950, and patient upper leg
4950.
[0041] The patient body support apparatus 4950 includes a patient
back support 4956, a shoulder restraint 4959, and a thigh restraint
4952.
[0042] FIG. 18 is a perspective view of a leg testing apparatus
5000 according to one aspect of the present inventions, which
includes left lower leg supporting apparatus 5200, right lower leg
supporting apparatus 5300, and lower frame number 5100. As maybe
seen, the "Z" axes of the two apparatuses 5200, and 5300, are not
aligned. This will be discussed elsewhere in this application.
[0043] FIG. 19 is a top elevation view of the leg testing apparatus
5000 of FIG. 18, illustrating the relationship of the left lower
leg supporting apparatus 5200 and the right lower leg supporting
apparatus 5300, relative to the inner surface of the scanning
device 4900. As may be seen, the "X" axes of the two apparatuses
5200, and 5300, are also not aligned, and in the embodiment shown,
the angle between the two is fixed.
[0044] FIG. 20 is a rear elevation view of the leg testing
apparatus 5000 of FIG. 18, which includes left lower leg supporting
apparatus 5200, right lower leg supporting apparatus 5300, and
lower frame number 5100.
[0045] FIG. 21 is a front elevation view of the leg testing
apparatus 5000 of FIG. 20.
[0046] FIG. 22 is a pictorial view of the right lower leg
supporting apparatus 5300, with certain elements not included for
purposes of explanation.
[0047] FIG. 23 is a right side elevation view of the right lower
leg supporting apparatus 5300, with certain elements not shown for
purposes of explanation.
[0048] FIG. 24 is a pictorial view of a portion of the right lower
leg supporting apparatus 5300 of FIG. 23, showing certain
details.
[0049] FIG. 25 is a pictorial view of a portion of the right lower
leg supporting apparatus 5300, taken from the opposite side as that
shown in FIG. 24.
[0050] FIGS. 26A and 26B show two sequential illustrative views
similar to FIG. 17, except that the leg testing apparatus 5000 is
configured to be moved between the two positions shown, resulting
in different flexions of the knee (Note that 26A knee is in a more
extended position than the 26B knee.)
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
[0051] Various embodiments of the present invention will now be
described more fully hereinafter with reference to the accompanying
drawings, in which some, but not all embodiments of the invention
are shown. Indeed, embodiments of the invention may be embodied in
many different forms and should not be construed as limited to the
embodiments set forth herein. Rather, these embodiments are
provided so that this disclosure will satisfy applicable legal
requirements. Unless otherwise defined, all technical and
scientific terms used herein have the same meaning as commonly
known and understood by one of ordinary skill in the art to which
the invention relates. The term "or" is used herein in both the
alternative and conjunctive sense, unless otherwise indicated. Like
numbers refer to like elements throughout.
I. ELEMENT LIST
[0052] 10 Overall RKT apparatus [0053] 20 main frame assembly
[0054] 30 support cushion [0055] 40 sliding support framework
[0056] 50 pivoting leg support frame assemblies (2) [0057] 60 knee
support/stabilizing assemblies (2) [0058] 80 thigh retention
assemblies (2) [0059] 1000 tibia positioning assembly [0060] 1100
sliding frame assembly (supports Y drive assembly) [0061] 1101
sliding frame members (FIG. 7) [0062] 1102 bearings (FIG. 7) [0063]
1103 flange adaptor (FIG. 7) [0064] 1104 torque transducer (Y axis)
[0065] 1110 frame cap assembly (attached to pivot plate) [0066]
1200 pivoting plate assembly (supports X/Z/yoke/calf) [0067] 1201
pivoting plate [0068] 1210 L-shaped flange brackets (2) (support X)
[0069] 1211 bearing (support X) [0070] 1212 stub flange (supports
yoke/calf) [0071] 1213 flange bracket (supports yoke/calf [0072]
1220 L bracket (support Z) [0073] 1221 flange adaptor (support Z)
[0074] 1222 torque transducer (Z axis) [0075] 1300 foot rotation
assembly [0076] 1400 yoke assembly (FIG. 4) [0077] 1410 yoke top
plate [0078] 1420 yoke end plates (2) [0079] 1430 limit plate
[0080] 1500 calf bias assembly [0081] 1510 side leg members (2)
[0082] 1520 plate [0083] 1530 torque transducer (X axis) [0084]
1540 stub flange [0085] 1550 bearing [0086] 1560 telescoping rod
assembly [0087] 1570 calf bias plate [0088] 2000 x-axis drive
assembly [0089] 2010 drive motor [0090] 2020 gear box [0091] 2030
output shaft [0092] 2100 y-axis drive assembly [0093] 2130 output
shaft [0094] 2200 z-axis drive assembly [0095] 2210 drive motor
[0096] 2220 gear box [0097] 2230 output shaft [0098] 3001 Spherical
member (with center C1) [0099] 3002 Spherical member (with center
C2) [0100] 3003 Spherical member (with center C3) [0101] 4000
Spherical cage [0102] 4900 Exemplary CT scanning device [0103] 4950
Patient body support apparatus [0104] 4951 Link [0105] 4952 Patient
thigh restraints [0106] 4956 Patient back support [0107] 4959
Patient shoulder restraint [0108] 4960 Patient body [0109] 4961
Patient upper body [0110] 4962 Patient upper leg [0111] 4964
Patient Lower leg [0112] 5000 Overall Leg Testing Apparatus [0113]
5100 Lower Frame Member [0114] 5101 Slide assemblies (4 shown)
[0115] 5200 Left Lower Leg Supporting Apparatus [0116] 5260 Calf
bias assembly [0117] 5300 Right Lower Leg Supporting Apparatus
[0118] 5400 X Drive Assembly (for AP) [0119] 5502 Vertical Shaft
[0120] 5504 Lower Bearing [0121] 5505 Upper Bearing [0122] 5507
Plate-to-shaft mounting flange [0123] 5600 Z Drive Assembly (for
internal and external rotation) [0124] 5300 Right Lower Leg
Supporting Apparatus [0125] 5310 Lower Vertical Frame Members (2)
[0126] 5312 Lower Frame Table [0127] 5314 Intermediate Vertical
Frame Members (2) [0128] 5320 Intermediate Frame Table [0129] 5322
Short Upper Vertical Frame Members (2) [0130] 5330 Upper Frame
Table [0131] 5332 Long Upper Vertical Frame Members (2) [0132] 5340
Pivoting Horizontal Foot Support Plate [0133] 5341 Pivoting
Vertical Foot Support Flange [0134] 5344 Foot Plate [0135] 5350
Yoke Assembly [0136] 5342 yoke top plate [0137] 5344 yoke end
plates (2) [0138] 5346 limit plate [0139] 5360 Calf bias assembly
(Similar to calf bias assembly 1500) [0140] 5362 Calf bias plate
[0141] 5363 Extendible rod assembly [0142] 5364 Side leg members
(2)
II. DETAILED DESCRIPTION
[0143] Reference will now be made in detail to one or more
embodiments of the present assembly, an example of which is
illustrated in the accompanying drawings. The embodiments are
described by way of explanation, and not by way of limitation.
Indeed, embodiments of the invention may be embodied in many
different forms and should not be construed as limited to the
embodiments set forth herein. Rather, these embodiments are
provided so that this disclosure will satisfy applicable legal
requirements.
[0144] A) The Overall Apparatus 10
[0145] 1. Generally
[0146] As illustrated in at least FIGS. 1-4, various embodiments of
the overall RKT (Robotic Knee Testing) device 10 may include the
following features: [0147] Main Frame Assembly 20 (FIG. 2); [0148]
Support Cushion 30 (FIG. 2); [0149] Sliding Support Framework 40
(FIG. 2); [0150] Two (2) Pivoting Leg Support Frame Assemblies 50
(FIG. 2); [0151] Two (2) Knee Support/Stabilizing Assemblies 60
(FIG. 2); [0152] Two (2) Thigh Retention Assemblies 80 (FIG. 2);
[0153] Two (2) Tibia Positioning Assemblies 1000 (FIG. 2); [0154]
Sliding Frame Assembly 1100 (FIG. 3); [0155] Pivoting Plate
Assembly 1200 (FIG. 4); [0156] Two (2) Foot Rotation Assemblies
1300 (FIG. 3); [0157] Yoke Assembly 1400 (FIG. 3); [0158] Calf Bias
Assembly 1500 (FIG. 3); [0159] "X"-axis Drive Assembly 2000 (FIG.
4): [0160] "Y"-axis Drive Assembly 2100 (FIG. 4); and [0161]
"Z"-axis Drive Assembly 2200 (FIG. 4).
[0162] With particular reference to FIG. 2, it should be understood
that according to various embodiments, at least certain elements of
the overall RKT device 10 may be sized, shaped, and/or configured
in substantially the same manner as the device described in
co-owned U.S. Patent Application Publication No. 2012/0046540-A1
(also Ser. No. 13/209,380), as published on Feb. 23, 2012 and filed
on Aug. 13, 2011, which is hereby incorporated by reference in its
entirety. As non-limiting examples, the main frame assembly 20, the
support cushion 30, the sliding support framework 40, the pivoting
leg support frame assembly 50, the knee support/stabilizing
assembly 60, and the thigh retention assembly 80 illustrated in at
least FIG. 2 may be configured, sized, and/or shaped substantially
the same as the comparable elements, as described in Ser. No.
13/209,380, which is, as previously noted, incorporated by
reference in its entirety herein. Of course, certain embodiments,
including those indicated hereinabove or otherwise, of the overall
RKT device 10 may have one or more of these elements sized, shaped,
and/or configured in a substantially different manner than that
described in Ser. No. 13/209,380, as may be desirable for one or
more applications.
[0163] In use, as will be described in further detail below, a
patient (see FIGS. 10-11) may be positioned within the various
embodiments of the overall RKT device 10, such that their knees are
adjacent the knee support/stabilizing assemblies 60, their thighs
are adjacent the thigh retention assemblies 80, and their feet are
retained within the tibia pivoting assemblies 1000, particularly
adjacent a foot plate 1300 thereof (see FIG. 4).
[0164] Movement of the lower leg of the patient may be detected by
non-invasive systems utilizes sensors or markers that are attached
to the skin, including but not limited to optoelectronic,
ultrasonic, and electromagnetic motion analysis systems.
[0165] 2. Tibia Positioning Assemblies 1000
[0166] According to various embodiments, with reference to FIG. 2,
the overall RKT device 10 comprises may comprise two tibia
positioning assemblies 1000, each generally configured to support
and/or constrain at least one of a patient's tibia and foot so as
to facilitate evaluation of movement thereof in response to the
imposition of one or more forces about one or more axes (e.g., the
X, Y, and/or Z axes, as described later herein). In certain
embodiments, the two the tibia positioning assemblies 1000 may be
substantially identical in size, shape, and configuration. In other
embodiments, only a single tibia positioning assembly 1000 may be
provided, for example, where only a single leg of a patient is of
concern for treatment.
[0167] It should be noted, however, that according to various
embodiments, at least the X-axis drive assemblies 2000 of FIG. 4
that form a portion of each tibia positioning assembly 1000 may be
configured so as to be substantially mirror images of one another,
even though such a configuration is not expressly illustrated in
FIG. 2. Instead, in the illustrated embodiment of FIG. 2, the "X"
axis drive assemblies 2000 (see again FIG. 4) are not substantially
mirror images of one another, as may be desirable for certain
applications. In those embodiments involving mirror image
positioned X axis drive assemblies 2000, however, it should be
understood that when certain movements (e.g., anterior-posterior,
varus-valgus, internal-external rotation, etc.) are imposed upon
the patient's limb during operation, the same movement and in
particular the same orientation of movement will be imposed upon
both limbs. As a non-limiting example, when anterior movement is
imposed upon a patient's first tibia via rotation of one of the
drive assemblies, the same activation signal will likewise impose
anterior movement upon the patient's second tibia in those
embodiments having the X axis drive assemblies positioned as
substantial mirror images relative to one another. In contrast, in
those other embodiments, as may be desirable for particular
applications, where the tibia positioning assemblies 1000 may not
be "mirror-imaged" relative to one another, a single activation
signal would impose anterior movement upon one tibia and posterior
movement upon the other (or varus upon one and valgus upon the
other, or internal rotation upon one and external rotation upon the
other, etc.). This should be understood with reference to at least
FIGS. 2 and 4 in concert with one another.
[0168] With that in mind and turning now to FIGS. 3 and 4 in
combination, various embodiments of each tibia positioning assembly
1000 (isolated for purposes of a concise and clear disclosure)
generally comprise a sliding frame assembly 1100, a pivoting plate
assembly 1200, a foot rotation assembly 1300, a yoke assembly 1400,
a calf bias assembly 1500, a X-axis drive assembly 2000, a Y-axis
drive assembly 2100, and a Z axis drive assembly 2200. These
assemblies will now be described, in turn, below.
[0169] 3. Sliding Frame Assembly 1100
[0170] According to various embodiments, each tibia positioning
assembly 1000 comprises a sliding frame assembly 1100 that provides
an interface between at least the Y-axis drive assembly 2100 and
the main frame assembly 20 of the RKT device 10. As may be seen
from FIG. 2, the sliding frame assembly 1100 is, in certain
embodiments, linearly slidable along the pivoting leg support frame
assembly 50, so as to accommodate varying lengths of patient legs.
In at least one embodiment, the sliding frame assembly 1100 may be
configured for translational movement relative to the pivoting leg
support frame assembly 50 and/or the main frame assembly 20 of the
RKT device 10 in a manner substantially the same as the sliding
frame 120 described in Ser. No. 13/209,380, as incorporated by
reference herein and as may be desirable for one or more
applications.
[0171] Turning for a moment to FIG. 7, it may be seen that the
sliding frame assembly 1100 generally comprises a plurality of
sliding frame members 1101, each configured to form a platform for
substantially supporting a first (e.g., lower positioned) portion
of the Y-axis drive assembly 2100. In certain embodiments, the
sliding frame assembly 1100 comprises a pair of bearings 1102 and a
flange adaptor 1103 configured to attach a second (e.g., higher
positioned) portion of the Y-axis drive assembly 2100 relative to
the pivoting plate assembly 1200, as will be described in further
detail below. A torque transducer 1104 may also be provided to
evaluate the torque along the drive line between an output shaft
2130 of the Y-axis drive assembly 2100 and a pivoting plate 1201,
all as will be described in further detail below. In these and
still other embodiments, the sliding frame assembly 1100 may
further comprise a frame cap assembly 1110, which incorporates a
plurality of members (shown, but not numbered) that cover (and thus
protect) the second portion of the Y-axis drive assembly 2100.
[0172] Remaining with FIG. 7 and also with reference to FIGS. 5-6,
it should be understood that the sliding frame assembly 1100,
beyond being configured to permit selectable translational movement
thereof relative to the main frame assembly 20 of the RKT device
10, is configured to support the Y-axis drive assembly 2100 such
that a longitudinal axis thereof lies substantially along the
Y-axis (see in particular FIGS. 5 and 6). In this manner, during
operation of the RKT device 10, activation of the Y-axis drive
assembly 2100 provides rotation about the Y-axis. As should be
understood from FIGS. 1-4 generally, such rotation about the
Y-axis, as has been previously mentioned, may in turn be configured
to impose varus-valgus movement upon an associated positioned
patient's leg.
[0173] It should also be noted, with reference to FIGS. 4-5 and 7,
and as will be described in further detail below in the context of
operation of the RKT device 10, the pair of bearings 1102 and the
flange adaptor 1103, which operatively connect the Y-axis drive
assembly 2100 and the sliding frame assembly 1100 relative to the
pivoting plate assembly 1200 are configured such that rotation
about the Y-axis results in corresponding movement of the foot
plate 1300 and thus the patient's foot and/or tibia about the same.
Such movements, imposed as the result of operation will, however,
be described in further detail elsewhere herein.
[0174] 4. Pivoting Plate Assembly 1200
[0175] Returning now with particular emphasis upon FIG. 4, the
pivoting plate assembly 1200 of the tibia positioning assembly 1000
is illustrated. The pivoting plate assembly 1200 according to
various embodiments comprises a pivoting plate 1201, which is
mounted relative to the sliding frame members 1101 of the sliding
frame assembly 1100 (see, e.g., FIG. 7). In certain embodiments, as
illustrated in FIG. 4, the pivoting plate 1201 is mounted to the
frame cap assembly 1110 (see again FIG. 7), so as to also provide a
platform for supporting the X-axis and Z-axis drive assemblies
2000, 2200, the configuration of which as will be described
elsewhere herein.
[0176] In various embodiments, as mentioned, the pivoting plate
assembly 1200 comprises a pivoting plate 1201 that is mounted to
the frame cap assembly 1110. In this manner, the mounting of the
pivoting plate 1201 relative to the frame cap assembly 1110 serves
to fixedly couple movement of the pivot plate 1201 to movement
imposed by the Y-axis drive assembly 2100 about the Y-axis.
[0177] The pivoting plate assembly 1200 according to various
embodiments further comprises a pair of L-shaped flange brackets
1210 (see FIG. 4), each configured to be mounted on opposing ends
of the pivoting plate 1201, such that the X-axis drive assembly
2000 may be mounted there-between. In certain embodiments, as may
be seen in FIG. 4, each of the L-shaped flange brackets 1210 may
comprise an opening configured to receive at least a portion of the
X-axis drive assembly 2000. In at least the illustrated embodiment,
the pivoting plate assembly 1200 further comprises a bearing 1211
and a stub flange 1212, each of which are mounted adjacent the
second of the two L-shaped flange brackets 1210, namely further
adjacent the drive motor 2010 of the X-axis drive assembly 2000. A
flange bracket 1213 is similarly attached adjacent the first of the
two L-shaped brackets 1210, namely substantially adjacent the gear
box 2020 of the X-axis drive assembly 2000. In this manner, the
L-shaped flange brackets 1210 provide stable support for the X-axis
drive assembly 2000.
[0178] With continued reference to FIG. 4, it should be understood
that the configuration of the previously described components of
the pivoting plate assembly 1200 relative to the X-axis drive
assembly 2000 are configured such that rotation of the X-axis drive
assembly substantially about the X axis (see FIG. 5) translates
into rotational movement of the yoke assembly 1400 and the calf
bias assembly 1500, both as will be described in further detail
below. Such movement is imparted due, at least in part, to the
further mounting of the flange bracket 1213 and the stub flange
1212 of the pivoting plate assembly 1200 to opposing ones of a pair
of side leg members 1510 of the yoke assembly 1500, again, as will
be detailed further below.
[0179] Beyond the above-described components of the pivoting plate
assembly 1200 configured to support and/or translate movement
imposed by the X-axis drive assembly 2000, the plate assembly 1200
further comprises according to various embodiments certain
components configured to support the Z-axis drive assembly 2200. In
particular, with continued reference to FIG. 4, it may be seen that
the pivoting plate assembly 1200 in certain embodiments further
comprises an L bracket 1220, a flange adaptor 1221, and a torque
transducer 1222, all oriented relative to and along the Z-axis.
[0180] The L bracket 1220 according to various embodiments is
mounted to the pivoting plate 1201 such that it is oriented
substantially perpendicular relative to the pair of L-shaped flange
brackets 1210 described previously herein as being configured for
supporting the X-axis drive assembly 2000. In this manner, as
illustrated further in FIGS. 5-6, it should be understood that the
X-axis drive assembly 2000 and the Z-axis drive assembly 2200 are
likewise positioned substantially perpendicular relative to one
another, so as to provide respective rotation about the likewise
mutually perpendicular X and Z axes.
[0181] The flange adaptor 1221 and the torque transducer 1222 are
likewise mounted to the L bracket 1220 and the foot plate 1300
(described elsewhere herein), such that rotational movement of the
Z-axis drive assembly 2200 is converted into a rotational force
about the Z-axis that is not only measured by the torque transducer
1222 (e.g., to ensure an appropriate or desired force is
supplied/imposed) but also transferred onto the foot plate 1300,
resulting in corresponding rotational movement thereof about the
Z-axis. Notably, as will be described further below, the rotational
movement of the foot plate 1300 about the Z-axis is configured to
provide internal and/or external rotation a patient's tibia during
operational testing performed according to various embodiments.
[0182] 5. Foot Rotation Assembly 1300
[0183] According to various embodiments, as may be understood from
at least FIGS. 3-4 and 7, the foot plate assembly 1300 of each of
the tibia positioning assemblies 1000 may be pivotably mounted
relative to the pivoting plate assembly 1200 of the (linearly)
sliding frame assembly 1100 via the Z-axis drive assembly 2200, as
will be described in further detail below. In certain embodiments,
the foot plate assembly 1300 is configured to rotate about the Z
axis in response to rotation of (e.g., to) an output shaft 2230 of
the Z axis drive assembly 2200 (see also FIG. 7), as will also be
described in further detail below. In these and still other
embodiments, with reference also to FIG. 4, the foot plate assembly
1300 is mounted in series to the torque transducer 1222, the flange
adapter 1221, and the L bracket 1220 of the pivoting plate assembly
1200.
[0184] With reference again to FIG. 3 and also to FIG. 10, it
should be understood that rotation of the foot plate assembly 1300
about the Z axis, as imposed by the Z-axis drive assembly 2200 is
configured to provide movement for tibia internal and external
rotation testing. Details of the drive assembly 2200 will be
described in further detail below in the context of operational
parameters of the RKT device 10.
[0185] It should also be understood, however, that rotation of the
pivoting plate assembly 1200 about the Y axis, via the "Y" Axis
drive assembly will also impose movement upon the foot plate 1300,
namely via its fixed mounting relative to at least the pivoting
plate assembly about the "Y" axis. In other words, in certain
embodiments, although the foot plate 1300 may be configured to
rotate about the Z axis, it may also be configured to move (e.g.,
to swivel) in response to rotation of the pivoting plate assembly
1200 about the Y axis, all as will be described in further detail
below.
[0186] 6. Yoke Assembly 1400
[0187] Returning to FIGS. 3-4 and 7, various embodiments of the
tibia positioning assembly 1000 further comprise a yoke assembly
1400. In certain embodiments, the yoke assembly 1400 comprises a
yoke top plate 1410, a pair of yoke end plates 1420, and at least
one limit plate 1430. Each of these components may be seen, in
particular, in the exploded view of FIG. 4.
[0188] Indeed, with particular reference to FIG. 4, the yoke end
plates 1420 are generally configured according to various
embodiments to operatively mount, respectively, to the flange
bracket 1213 and the stub flange 1212 of the pivoting plate
assembly 1200, as such components have been previously described
herein. In certain embodiments, respective side leg members 1510 of
a calf bias assembly 1500, as will be described below, may be
positioned intermediate the yoke end plates 1420 and the respective
flange bracket 1213 and stub flange 1212. In this manner, as will
be described in further detail below, rotational forces imposed by
rotational movement of the X-axis drive assembly 2000 about the
X-axis may be transferred from the drive assembly 2000 and onto
both the side leg members 1510 of the calf bias assembly 1500 and
the yoke end plates 1420 of the yoke assembly 1400.
[0189] Remaining with FIG. 4 and also with reference to FIG. 5, it
may be seen that the yoke top plate 1410 is, according to various
embodiments, positioned so as to extend substantially between the
respective yoke end plates 1410. In this manner, as rotational
movement of the X-axis drive assembly 2000 transfers rotational
movement onto the yoke end plates 1420, the latter further
transfers the same rotational movement onto the yoke top plate
1410. In certain embodiments, the limit plate 1430 of the yoke
assembly 1400 may be further configured with at least two rubber
stops that are positioned so as to contact opposing sides of the
yoke top plate 1410 and thus define a "limited" range of motion
thereof, in response to rotational movement imposed by the X-axis
drive assembly 2000. In this manner, a degree of movement and/or
force and/or torque that may be imposed upon a patient's limb may
be restricted for joint protection and/or patient comfort
[0190] Still further, it should be appreciated that the yoke
assembly 1400, and in particular, the yoke end plates 1420 are
further configured to transfer rotational movement imposed by the
X-axis drive assembly 2000 onto at least the side leg members 1510
of the calf bias assembly 1500, as described immediately below. Of
course, in certain embodiments, it should be appreciated that it is
the flange bracket 1213 and the stub flange 1212 of the pivot plate
assembly 1200 and their respectively fixed mounts to each of the
yoke end plates 1420 and the side leg members 1510 that transfers
the rotational movement thereupon. In other embodiments, the yoke
assembly 1400 may be otherwise configured, as may be desirable for
particular applications.
[0191] Returning for a moment to FIG. 4, with reference also to
FIGS. 10-11, it should be appreciated that the above-described
transference of rotational force (and thus movement) from the
X-axis drive assembly 2000 is configured such that the RKT device
10 may pivot, as illustrated, along the X-axis, so as to move a
patient's tibia from the illustrated position of FIG. 10 to that of
FIG. 11 (and vice versa). Of course, such rotation involves not
only rotational movement of the yoke assembly 1400 about the
X-axis, but also the same by the calf bias assembly 1500, which
will now be described immediately below. As also described in
further detail below, in certain embodiments, such movement may
impose rotational movement of the patient's limb, whether about the
same X-axis or about a secondary and parallel X-axis, as may be
seen in at least FIG. 10. These and other features, as may be
appreciated better with consideration to relative movements imposed
during operation of the RKT device will be described in further
detail below.
[0192] 7. Calf Bias Assembly 1500
[0193] According to various embodiments, returning again to FIG. 4,
the tibia positioning assembly 1000 further comprises a calf bias
assembly 1500, which may itself comprise a pair of side leg members
1510, a cross plate 1520, a torque transducer 1530, a stub flange
1540, a bearing 1550, a telescoping rod assembly 1560, and a calf
bias plate 1570.
[0194] With continued reference to FIG. 4, the pair of side leg
members 1510 are, according to various embodiments, fixedly
attached at a first end thereof to the flange bracket 1213 and the
stub flange 1212 of the pivoting plate assembly 1200, which also
supports at least the X-axis drive assembly 2000 and the yoke
assembly 1400. In this manner (i.e., via this
connection/attachment), the calf bias assembly 1500 is likewise
supported by the pivoting plate assembly 1200 according to various
embodiments.
[0195] Opposing ends of the side leg members 1510 are configured
according to various embodiments to mate with either a stub flange
1540/bearing 1550 pairing or a torque transducer 1530. Such is
configured substantially the same as the torque transducer 1222 and
the bearing 1211/stub flange 1212 pairing previously described
herein. In other words, the torque transducer 1530 is configured to
measure and transfer a force imposed upon the side leg members 1510
by the X axis drive assembly 2000 onto at least the plate 1520
and/or the calf bias plate 1570 of the calf bias assembly 1500.
[0196] Returning to FIG. 4, a plate 1520 and a telescoping rod
assembly 1560 are also provided and configured to fixedly link the
torque transducer 1530 to the calf bias plate 1570. With reference
to FIGS. 10-11, and as will be described in further detail below,
this configuration facilitates transfer of the rotational force
(and thus torque) imposed upon the yoke assembly 1400 by the X-axis
drive assembly 2000 onto not only the calf bias assembly 1500, but
also the patient's tibia positioned substantially adjacent to the
calf bias plate 1570. Indeed, as should be understood from these
figures, imposing a force in the clockwise direction (relative to
FIGS. 10-11, in particular) results in a substantially "upward"
movement of the tibia, further accompanied by rotation about the
illustrated tibia pivot point. In this manner, as will be described
in further detail, activation of the X axis drive assembly results
in forces being applied to the tibia substantially along the Y axis
in the anterior and/or posterior direction relative to the
tibia.
[0197] Although reference has been made herein to a telescoping rod
assembly 1560, which should be understood to be extendable in
length (e.g., between the calf bias plate 1570 and the plate 1520
adjacent the pivoting plate assembly 1200, certain embodiments may
have otherwise configured assemblies 1560, provided such are
capable of accommodating differing lengths of patient's legs
positioned adjacent thereto. In still other embodiments, the rod
assembly 1560 may even not be adjustable, in a telescoping fashion
or otherwise, as may be desirable for particular applications.
[0198] 8. "X"-Axis Drive Assembly 2000
[0199] Remaining with FIG. 4, the X-axis drive assembly 2000 is
illustrated, as configured such that a longitudinal axis thereof
lies substantially along the further illustrated X-axis, as also
defined in at least FIG. 5. With reference to FIGS. 7 and 12, it
should be understood that various embodiments of the X-axis drive
assembly 2000 comprise a drive motor 2010, a gear box 2020, and an
output shaft 2030 operatively coupled to the gear box.
[0200] In certain embodiments, the drive motor 2010 may comprise a
servomotor configured to provide a rotational force, although still
other embodiments may include alternative mechanical or even manual
methods of force generation and application, as may be desirable
for particular applications and as commonly known and understood in
the art. Of course, it should be understood that any of a variety
of alternative configurations may be envisioned as within the scope
of the present invention, as may be desirable for a given
application.
[0201] In certain embodiments, the drive motor 2010, however
particularly configured, may be at least configured with a housing
mounted relative to the pivoting plate assembly 1200, such that the
drive motor drives the corresponding output shaft 2030, which
itself drives at least the yoke assembly 1400 and the calf bias
assembly 1500 based upon the structural relationships previously
described herein. In this manner, according to various embodiments,
the X-axis drive assembly 2000 is configured to facilitate rotation
of at least a portion of the RKT device 10 about the X-axis (see
FIG. 5), such that a user of the device may evaluate "AP"
(anterior-posterior) movement of the tibia with respect to the
femur at the knee about an X-axis of rotation distal to the
foot.
[0202] 9. "Y"-Axis Drive Assembly 2100
[0203] Turning now with particular reference to FIG. 7, the Y-axis
drive assembly 2100 is illustrated, as may be configured according
to various embodiments such that a longitudinal axis thereof lies
substantially along the Y-axis, the latter of which as is defined
in at least FIG. 5. With reference to FIG. 12, it should be
understood that various embodiments of the Y-axis drive assembly
2100 comprise a drive motor 2110, a gear box 2120, and an output
shaft 2130 operatively coupled to the gear box.
[0204] In certain embodiments, the drive motor 2110 may comprise a
servomotor configured to provide a rotational force, although still
other embodiments may include alternative mechanical or even manual
methods of force generation and application, as may be desirable
for particular applications and as commonly known and understood in
the art. Of course, it should be understood that any of a variety
of alternative configurations may be envisioned as within the scope
of the present invention, as may be desirable for a given
application.
[0205] In certain embodiments, the drive motor 2110, however
particularly configured, may be at least configured with a housing
mounted relative to the pivoting plate assembly 1200, such that the
drive motor drives the corresponding output shaft 2130, which
itself imposes rotation upon at least the pivoting plate assembly
1200 and the foot plate assembly 1300 based upon the structural
relationships previously described herein. In this manner,
according to various embodiments, the Y-axis drive assembly 2100 is
configured to facilitate rotation of the foot plate assembly 1300
about the Y-axis (see FIG. 6), such that a user of the device may
evaluate varus-valgus conditions about a Y-axis of rotation distal
to the foot.
[0206] 10. "Z"-Axis Drive Assembly 2200
[0207] Returning again to FIGS. 4 and 12, the Z-axis drive assembly
2200 is illustrated according to various embodiments, as may be
configured such that a longitudinal axis thereof lies substantially
along the Z-axis, the latter of which as is defined in at least
FIG. 5. With reference to FIG. 12, it should be understood that
various embodiments of the Z-axis drive assembly 2200 comprise a
drive motor 2210, a gear box 2220, and an output shaft 2230
operatively coupled to the gear box.
[0208] In certain embodiments, the drive motor 2210 may comprise a
servomotor configured to provide a rotational force, although still
other embodiments may include alternative mechanical or even manual
methods of force generation and application, as may be desirable
for particular applications and as commonly known and understood in
the art. Of course, it should be understood that any of a variety
of alternative configurations may be envisioned as within the scope
of the present invention, as may be desirable for a given
application.
[0209] In certain embodiments, the drive motor 2210, however
particularly configured, may be at least configured with a housing
mounted relative to the foot plate assembly 1300 based upon the
structural relationships previously described herein. In this
manner, according to various embodiments, the Z-axis drive assembly
2200 is configured to facilitate rotation of the foot plate
assembly 1300 about the Z-axis (see FIG. 6), such that a user of
the device may evaluate (internal-external) movement about a Z-axis
of rotation.
[0210] It should further be understood that any of the X-, Y-, or
Z-axis drive assemblies 2000-2200 may be structurally configured
substantially the same relative to one another, with the only
substantive difference being the relative axis of rotation about
which each is oriented. Of course, it should also be understood
that any of a variety of alternative configurations may be
envisioned as within the scope of the present invention, as may be
desirable for a given application.
[0211] It should also be understood that although in certain
embodiments, the X-, Y-, and/or Z-axis drive assemblies 2000-2200
may be oriented such that at least two thereof are mutually
orthogonal and intersecting relative to one another, in other
embodiments, one or more of the drive assemblies 2000-2200 may be
offset relative to the remainder of the drive assemblies, such that
non-intersecting, although orthogonal axes are defined. This
feature and further variations thereof are described in further
detail elsewhere herein, and may be understood generally with
reference to at least FIG. 7 (showing how the Y and X axis may be
offset relative to one another, as along a longitudinal axis of the
RKT device in its entirety); FIGS. 8 and 9 (showing the same
relative offset between the X and Y axes, when viewed in
combination); and FIGS. 13-15 (as will be described elsewhere
herein).
[0212] B) Overall Operation
[0213] Each of the various above-described features and their use
will now be described in further detail herein-below.
[0214] 1. Generally
[0215] Three drive assemblies are used, namely a "X" axis drive
assembly 2000, a "Y" axis drive assembly 2100, and a "Z" axis drive
assembly 2200. Each drive assembly can be understood to include, in
various embodiments, a mounting frame, a drive motor and a gearbox
having an output shaft, as all previously described herein. By
operation of any of the drive motors, rotational movement is
provided to a corresponding output shaft with intermediate
reduction (or expansion) gearing as needed to provide adequate
torque and rotational speed.
[0216] According to various embodiments, torque sensors are
provided in the power line in order to provide torque readings as
known in the art relating to each of these three drive assemblies.
These torque readings may be calibrated and calculated as needed to
correspond to known torque or force values imparted to a patient's
limb(s).
[0217] As noted elsewhere, movement of the patient's body parts may
be detected by non-invasive systems utilizes sensors or markers
that are attached to the skin, including but not limited to vision,
optoelectronic, ultrasonic, and electromagnetic motion analysis
systems.
[0218] The three drive assemblies are configured about mutually
perpendicular X-, Y-, and Z-axes of rotation, as illustrated in at
least FIG. 5. As such, the respective forces (and corresponding
torque) imposed by the drive assemblies are configured to
selectively evaluate "AP" (anterior-posterior) movement of the
tibia with respect to the femur at the knee about the X-axis of
rotation distal to the foot, varus-valgus conditions about the
Y-axis of rotation distal to the foot, and "IE" (internal-external)
movement about the Z-axis of rotation. Similarly, motions can be
defined in such a way as to be relative to a co-ordinate system
defined by the tibia as opposed to the femur.
[0219] According to various embodiments, the patella is clamped in
place for all three types of testing procedures. In these and still
other embodiments, a strap (not illustrated) may be coupled with
the calf bias plate of assembly 1500 for use only during AP
testing. Such a strap/plate or cage or box assembly may be
configured as commonly known and understood in the art so as to
provide selective restraint of the user's limb (e.g., as a
non-limiting example, the strap may be operatively connected to one
or the other sides of the calf bias plate 1570 and selectively
attachable (e.g., via Velcro or the like) on the opposing side,
with the strap also being in certain embodiments, selectively
adjustable, as may be desirable). The strap/plate, cage or box
assembly could be situated such that all sides are in constant
contact with the calf or it could be configured such that there is
space between the strap/plate, cage or box assembly and the calf.
When there is space the assembly will move for a small distance
before it contacts the calf and applies appropriate forces.
[0220] 2. X-Axis Drive Operation due to Component Relationships
[0221] Movement about the X axis is configured to provide "AP"
(anterior-posterior) movement of the tibia, due to forces up or
down on the tibia as the foot is maintained in a stationary
position by the foot plate assembly 1300. In particular, the tibia
pivots about an X oriented axis passing through the ankle--note
this is a different X axis (albeit parallel) to the X axis "of the
machine", aka the "machine X axis," all of which may be understood
with reference to FIG. 11.
[0222] With reference to FIG. 4, according to various embodiments,
the X drive assembly 2000 has its frame attached to the first of
the two L-shaped flange brackets 1210, which is itself attached to
the pivoting plate 1201. The output shaft of the X drive assembly
goes through the hole in the L-shaped flange bracket (1st of 2),
which in certain embodiments has a larger hole than its sister
L-shaped bracket (2.sup.nd of 2). The output shaft of the X drive
assembly drives a flange bracket 1213, which drives one end of a
side leg member 1510 of the calf bias assembly 1500, as previously
described herein. A yoke end plate 1420 and the flange bracket 1213
sandwich the end of the side leg member, such that relative
movement is transferred there-between during operation.
[0223] The yoke end plate 1420 is part of a rigid yoke assembly
1400 that includes a yoke top plate 1410 and two yoke end plates
1420. Notably, during operation according to various embodiments,
as the 1.sup.st of the two yoke end plates rotate about the X axis
so does the entire yoke assembly 1400. The 2.sup.nd yoke end plate
1420 is attached to the upper one end of a 2.sup.nd of two side leg
members 1510 of the calf bias assembly 1500, with that end also
being attached to a stub flange 1212 that is pivotably mounted
relative to the 2.sup.nd of two flange brackets. The bearing 1211
supporting the stub flange 1212 does not interact with the X axis
drive assembly 2000, such that the X axis drive assembly is thus
solely supported by the 1.sup.st of two flange brackets 1210, as
attached to the pivoting plate 1201.
[0224] As previously described herein, the lower end of the
1.sup.st of two side leg members 1510 is attached to a spool-shaped
torque transducer 1530, which is itself attached to a plate 1520
which supports a telescoping rod assembly 1560 that supports a calf
bias plate 1570.
[0225] The lower end of the 2.sup.nd of 2 side leg members 1510 has
a bearing 1550 attached thereto, which supports stub flange 1540.
This stub flange 1540 is attached to the end of the plate 1520
opposite the spool-shaped torque transducer.
[0226] In this manner, upon activation of the X-axis drive
assembly, any rotational force generated by the drive thereof is
transferred to the associated gear box 2020 and output shaft 2030,
the latter of which rotates the flange bracket 1213. Rotation of
the flange bracket 1213 causes rotation of the side leg member 1510
of the calf bias assembly 1500, which is operatively coupled to the
calf bias plate 1570 via at least a telescoping rod assembly 1560,
which may include one or more telescoping rods configured to
accommodate varying patient limb lengths.
[0227] The resulting movement imposed upon the calf bias plate 1570
is further illustrated in FIGS. 10-11, wherein pre- and
post-movement positions are respectively shown. As may be further
understood from these figures, rotation occurs not only about the
X-axis about which the X drive assembly 2000, but also about a
tibia pivot point about a stationary constrained ankle, as
restrained in the foot rotation assembly 1300. In this manner, a
user of the device may selectively evaluate "AP"
(anterior-posterior) movement of the tibia with respect to the
femur at the knee about an X-axis of rotation distal to the foot.
In certain embodiments, such selective evaluation involves
selective locking of the one or more of the remaining Y- and Z-axis
drive assemblies, upon activation of the X-axis drive assembly
2000. This selective locking can result in the foot remaining still
while the x-axis motor rotates about the X-axis distal to the foot
resulting in the calf being manipulated in the anterior-posterior
direction representing Y-axis translation.
[0228] 3. Y-Axis Drive Operation due to Component Relationships
[0229] The Y-Axis drive assembly 2100 is configured according to
various embodiments to rotate the foot plate about the Y axis
relative to the sliding frame assembly 1100, so as to evaluate
varus-valgus conditions. The strap associated with the calf support
member is not used. However the patella is clamped in place, as
previously described herein.
[0230] As described previously herein with reference to FIG. 7, the
frame of the Y axis drive assembly 2100 is attached to the
underside of the pivoting plate 1201 (see also FIG. 4), and
includes an output shaft 2130 that extends upwardly through a hole
in the pivot plate. This output shaft 2130 attaches to a flange
adaptor 1103 that attaches to a Y torque transducer 1104, which in
turn attaches to a frame cap assembly 1110, which attaches to the
pivoting plate 1201, all as also previously described herein. The
torque transducer 1104 thus evaluates the torque along the drive
line between the output shaft 2130 and the pivoting plate 1201.
[0231] With continued reference to FIGS. 4 and 7, it may be
understood that because the output shaft 2130 of the Y-axis drive
assembly 2100 and the foot plate 1300 are both fixedly attached to
the pivoting plate (e.g., the latter via the L bracket 1220, as
previously described herein), rotation transferred from the Y-axis
drive assembly 2100 onto the pivoting plate 1201, resulting in it
pivoting about the Y axis, is thus transferred further onto the
foot plate 1300, also causing it to move about the Y axis. Notably,
when such occurs without concurrent rotational transfer from the
Z-axis drive assembly 2100, movement of the foot plate 1300 will
thus be isolated to about the Y axis, with no rotation occurring
about the Z-axis.
[0232] During operation, such isolated rotation about the Y axis
facilitates evaluation of varus-valgus conditions about the Y-axis
of rotation, as previously described herein. Note that rotation of
about the Y-axis distal to the foot causes the foot to move in an
X-axis translation which results in a Y-axis rotation about the
knee. It is this Y-axis rotation at the knee that is the
varus-valgus rotation. Note that the distance from the footplate to
the motor determines how far the footplate will translate along the
X-axis. The more the footplate translates along the X-axis the more
varus-valgus movement is effected at the knee. Furthermore, the
Y-axis motor may be position such that it moves the footplate but
that the X-axis motor and/or the Z-axis motor are not moved during
the process.
[0233] 4. Z-Axis Drive Components and Operation
[0234] The Z-Axis drive assembly is configured to rotate the foot
plate about the Z axis relative to the sliding frame member, so as
to evaluate "IE" (internal-external) rotational movement of the
patient's tibia and/or limb. The strap associated with the calf
support member is not used.
[0235] With reference to FIG. 4, the foot plate 1300 is attached to
a torque transducer "IE" (internal-external) movement 1222 which is
attached to a flange adaptor 1221 which is attached to the output
shaft 2330 (see FIG. 12) of the Z-Axis drive assembly 2300. The
frame of the Z-Axis drive assembly is attached to an L Bracket 1220
which is fixedly attached to the pivot plate 1201, as described
elsewhere. Also as described elsewhere, the pivot plate 1201 is
attached relative to the linearly sliding frame assembly 1100 about
a pivoting axis Y. However, if the Y-Axis drive assembly is not in
use and is selectively locked (which it is capable of, as are the
other two), then the pivot plate 1201 is likewise substantially
rigidly attached relative to the sliding frame assembly 1200.
[0236] In this manner, upon activation of the Z-axis drive assembly
2200, a rotational movement and accompanying torque are transferred
via the output shaft 2330 directly to the foot plate 1300, thereby
providing resulting rotation of the foot plate about the Z-axis.
Such permits users to, amongst other things, evaluate "IE"
(internal-external) rotational movement of the patient's tibia
and/or limb.
[0237] 5. Right Versus Left Oriented Tibia Positioning Assemblies
1000
[0238] Although it has been previously described herein with
reference to FIG. 2, it should be again noted that although only
one tibia positioning assembly 1000 has been described herein,
various embodiments of the overall RKT device 10 comprise two such
assemblies 1000. In certain embodiments, the two assemblies are
symmetrical mirror images of one another, about a center-line axis
of the device 10 as a whole. In this manner, it should be
understood that, as a non-limiting example, if the same activation
signal is sent to each of the X-axis drive assemblies 2000, the
resulting movement of each will result in anterior movement of both
of the user's tibias. Consider the alternative, in the absence of a
symmetrical mirror image configuration, in which instance such a
signal would result in anterior movement of one tibia and posterior
movement of the other. Although such a nonsymmetrical configuration
may be desirable in at least one embodiment, it should be
understood that according to certain embodiments described herein,
the assemblies 1000 should be understood to be substantially
symmetrically configured.
[0239] Still further, it should be understood that although the
previous description has focused upon a single tibia positioning
assembly 1000, both of the assemblies of the overall RKT device 10
are according to certain embodiments configured, sized, and shaped
in substantially the same manner. Of course, it should also be
appreciated that in still other embodiments, it may be desirable to
have substantially differently sized, shaped, and/or configured
tibia positioning assemblies 1000, such as the non-limiting example
whereby at least one of the two assemblies substantially
corresponds to the tibia positioning assembly described in Ser. No.
13/209,380, as has been incorporated by reference herein in its
entirety.
[0240] 6. Drive Assembly Decoupling
[0241] It should be understood that any drive assembly
configuration 2000-2200 may be according to various embodiments
decoupled from any of the other two. In fact, each of the three
drive configurations could be decoupled from each of the other two
so that substantially independent rotation about the respective
axes thereof may be provided and thus imposed upon the patient's
limb, as may be desirable for particular applications. In still
other embodiments, it should be understood that two or more, and
even all three drive assemblies 2000-2200 may be mutually coupled
relative to one another such that movements are substantially
simultaneously imposed upon the patient's limb during operation of
the overall RKT device. That being said, it is often advantageous
to isolate each respective movement; thus isolation (i.e.,
decoupling) of the movements of each of the respective drive
assemblies 2000-2200 may be likewise desirable for particular
applications as have been described elsewhere herein.
[0242] C) Additional Configurations
[0243] 1. Spherical Configurations
[0244] Spherical configurations can be also be used to provide
manipulation of the lower leg of a patient about the centers of the
spheres.
[0245] FIG. 13 is an alternate configuration showing the use of
spherical elements 3001, 3002 for manipulating the lower leg of a
patient (shown in dotted line) about the centers of the
spheres.
[0246] Sphere 3001 is driven by the exemplary roller and drive
assembly (which can include two rollers and one cylindrical drive
member as known in the "mouse-ball" art). Depending on the number
of and orientation of roller and drive assemblies used in
conjunction with the sphere 3001, it may be understood that the
sphere 3001 may be rotated about its center C1 about a number of
rotational axes passing through the center C1, including at least
three mutually orthogonal axes. In this configuration the Center C1
is approximately in the center of the ankle of the user.
[0247] Sphere 3002 is driven by the exemplary roller and drive
assembly (which can also include two rollers and one cylindrical
drive member as known in the "mouse-ball" art, although these are
not shown). Depending on the number of and orientation of roller
and drive assemblies used in conjunction with the sphere 3002, it
may be understood that the sphere 3002 may be rotated about its
center C2 about a number of rotational axes passing through the
center C2, including at least three mutually orthogonal axes. In
this configuration the Center C2 is distal to the ankle and foot of
the user.
[0248] It may be understood, therefore, that such a spherical-based
configuration could be used to provide at least some of the
rotational movements described in association with FIGS. 1-12.
[0249] FIG. 14 is an alternate configuration showing the use of a
spherical element 3003, except that the center of rotation C3 is
even further distal to the foot, and an exemplary calf bias member
(aka extender bar) is also used for the AP movement only, with the
two other movements being provided without the bias member.
[0250] FIG. 15 shows an alternate configuration including a
spherical cage 4000 comprised of a plurality of cage bars 4005.
Rotation of the cage is done by use of one or more stationary
motors such as 4010.
[0251] Stationary motor 4010 and rollers 4020 are mounted relative
to frame member 4011. Motor 4010 drives rollers 4020, with the two
rollers capturing an associated cage bar. This rotation of the
spherical cage 4000 can be provided about an axis extending through
the center of the cage and normal to a plane including the
particular arcuate cage bar. Either of or both rollers can drive
the bar. The point of this is to illustrate that many types of
drive configurations can be used to provide the motions in certain
of the embodiments herein, either from the inside of the sphere, or
the outside.
[0252] 2. Additional RKT Features
[0253] Note that the semicircular notch (not numbered) in the
pivoting plate 1201 (see for example just under the "Z" axis DRIVE
ASSEMBLY 2200 in FIG. 4) is configured to accept a vertical support
shaft (not shown) which is anchored at its base and extends
upwardly through the plate. The shaft has two slide bearings (not
shown) on either side which bear on the two primary planar surfaces
of the pivoting plate. This limits up and down deflection of the
plate from its pivot point during the AP testing process. During
the Y-axis movement, the shaft moves within the slot.
[0254] As previously mentioned, it should be understood that any
drive configuration could be decoupled from any of the other
two--in fact, each of the three drive configurations could be
decoupled from each of the other two so that substantially
independent rotation about the respective axes thereof may be
provided and thus imposed upon the patient's limb, however, as may
be desirable for particular applications.
[0255] In still other embodiments, it should be understood that two
or more, and even all three drive assemblies 2000-2200 may be
mutually coupled relative to one another such that movements are
substantially simultaneously imposed upon the patient's limb during
operation of the overall RKT device. That being said, it is often
advantageous to isolate each respective movement; thus isolation
(i.e., decoupling) of the movements of each of the respective drive
assemblies 2000-2200 may be likewise desirable for particular
applications as have been described elsewhere herein.
[0256] 3. RKT Device for CT Scanning
[0257] Additional details regarding imaging protocols, including
the use of CT scanning components in conjunction with limb and
ligament evaluation apparatuses may be found in Applicant's
commonly owned U.S. Patent Application Publication No.
2012/0046540-A1 (also Ser. No. 13/209,380), as published on Feb.
23, 2012 and filed on Aug. 13, 2011, which is hereby incorporated
by reference in its entirety.
[0258] Further very general disclosure of incorporation of CT
scanning components within limb and ligament evaluation apparatuses
may be found in Applicant's commonly owned U.S. Patent Application
Publication No. 2009/0124936-A1 (also Ser. No. 12/267,109), as
published on May 14, 2009 and filed on Nov. 7, 2008, which is
hereby incorporated by reference in its entirety.
[0259] Here begins a discussion of a second embodiment RKT device
5000, which includes similarities to the above-described RKT device
B, but also includes differences. Some of these differences
facilitate its use in conjunction with a CT scanner to evaluate the
knee of a human. However, it should be understood that this is not
to be limited to such scanners or joints, and is only an example.
The device 5000 could also be used in conjunction with MRI or other
scanners, and indeed some of its features may be used with sensors
such as those used with the non-radiographic device 10 above, which
include non-invasive systems utilizing sensors or markers that are
attached to the skin, including but not limited to optoelectronic,
ultrasonic, and electromagnetic motion analysis systems.
[0260] Reference is first made to FIG. 17, which is a side
illustrative view of a leg testing apparatus 5000 according to one
of the inventions herein, in combination with an exemplary CT
scanner 4900, and a patient's body support apparatus 4950. The
three devices are configured to be typically situated atop an
unnumbered supporting surface. Also shown is an exemplary patient,
including a patient proper body 4951, patient lower leg 4950, and
patient upper leg 4950.
[0261] It may be understood that inventions and novelties relate to
and include the leg testing apparatus 5000 and its use on its own,
as well as the leg testing apparatus 5000 and its use in
combination with the CT scanner 4900, as well as the leg testing
apparatus 5000 and its use in combination with the patient body
support apparatus 4950, as well as the three components 5000, 4950,
and 4900 together.
[0262] As may be understood, the leg testing apparatus 5000
manipulates the leg of the patient, while the patient is supported
on the patient body support apparatus 4950. A portion of the
patient's body, in this example the lower leg, is shown in FIG. 17
as within the opening of the CT scanner 4900, such that the lower
leg can be scanned by the CT scanner. This scanning may be done
while the leg testing apparatus is in any one of a multiplicity of
modes of operation, including but not limited to its testing of the
patients knee in "AP" (anterior-posterior) movement, varus-valgus
movement, and/or internal and external rotation.
[0263] The upper torso of the patient is supported by the patient
body support apparatus 4950, which includes a back support 4956
(upon which the patient lies), which supports a thigh restraint
assembly 4952 (which contains the upper thighs of the patient), and
which also supports a shoulder restraint 4959 (which serve to
discourage the patient from moving to the right as FIG. 17 is
viewed.
[0264] It may be understood that under one embodiment of the
invention, the patient body support apparatus 4950 includes a
structural link member 4951 which connects to the leg testing
apparatus 5000, to allow the two to slide together as a unit (with
both 5000 being on rollers or suitably aligned tracks).
Alternately, the two members could be separately driven via
coordinated synchronized drive means.
[0265] Reference is now made to FIG. 18, which is a perspective
view of a leg testing apparatus 5000 according to one aspect of the
present inventions, which includes left lower leg supporting
apparatus 5200, right lower leg supporting apparatus 5300, and
lower frame number 5100.
[0266] As may be seen, in FIG. 18, the "Z" axes of the two
apparatuses 5200, and 5300, are not aligned with each other. These
two axes are referenced as "Z axis--left", the Z axis of the left
apparatus 5200, and "Z axis--right", the Z axis of the right
apparatus 5300. The Z axis for purpose of this discussion should be
understood as the axis of rotation of the foot plate as discussed
in later detail
[0267] In FIG. 18, these two Z axes are positioned in "alignment"
with their related calf bias assemblies 5260, 5360. However it will
be understood from later discussion that while the positions of the
"Z" axes of the two apparatuses 5200 and 5300 can be varied, the
calf bias assemblies are not configured to rotate about a vertical
axis (although they can each rotate about their own horizontal "X"
axis to provide an AP action). This is to accommodate the use of
the apparatus 5000 within the relatively narrow space within the CT
scanner.
[0268] FIG. 19 is a top elevation view of the leg testing apparatus
5000 of FIG. 18, illustrating the relationship of the left lower
leg supporting apparatus 5200 and the right lower leg supporting
apparatus 5300, relative to the inner surface of the scanning
device 4900. As may be seen, the "X" axes of the two apparatuses
5200, and 5300, are also not aligned, and in the embodiment shown,
the angle between the two is fixed.
[0269] FIG. 20 is a rear elevation view of the leg testing
apparatus 5000 of FIG. 18, which includes left lower leg supporting
apparatus 5200, right lower leg supporting apparatus 5300, and
lower frame number 5100. FIG. 21 is a front elevation view of the
same leg testing apparatus 5000.
[0270] FIG. 22 is a pictorial view of the right lower leg
supporting apparatus 5300, with certain elements not included for
purposes of explanation. In reference to this as well as Figures G
and H--for example, here follows a description of right leg
supporting apparatus 5300; a similar description could be made of
left lower leg supporting apparatus 5200, as the two are
essentially mirror images of each other.
[0271] The right lower leg supporting apparatus 5300 is slidably
mounted relative to the lower frame member via slide assemblies
5101, such that the two apparatuses 5200, 5300, slide in tandem
along parallel slide paths. There are smaller slide mounts that
allow 5200 and 5300 to slide independently along the same path.
[0272] The two slide assemblies 5101 are attached to the bottom of
corresponding two lower vertical frame members 5310. A lower frame
table 5312 is rigidly attached to the top of the two lower vertical
frame members 5310.
[0273] Two intermediate vertical frame members 5314 are rigidly
attached to the top of the lower frame table 5312. An intermediate
frame table 5320 is rigidly attached to the top of the two
intermediate vertical frame members 5314.
[0274] Two short upper vertical frame members 5322 are rigidly
attached to the top of the upper frame table 5312. An upper frame
table 5333 is rigidly attached to the top of the two short upper
vertical frame members 5322.
[0275] Two long upper vertical frame members 5332 are also rigidly
attached to the top of the upper frame table 5312. These frame
members support the X drive assembly 5600 in a manner similar to
that described in the apparatus earlier in this application.
[0276] 4. "X"-Axis Drive Assembly 5600 Construction and
Operation
[0277] The "X"-axis Drive Assembly 5600 is configured to drive the
calf bias assembly 5360 substantially about the X axis, similar to
the manner in which the calf bias assembly 1500 of the device 10
described above was driven by its "X"-axis Drive Assembly 2000.
Torque about the X axis is also similarly determined by a similar
torque transducer. As in device 10, this provides for an evaluation
of "AP" (anterior-posterior) movement of the tibia with respect to
the femur at the knee about an X-axis of rotation distal to the
foot. It should be understood that such an evaluation, as with any
of the movements herein, includes an evaluation of the degree of
rotation or pivot as well as the torque involved during such
rotation or pivoting.
[0278] 5. "Y" Drive Assembly Construction and Operation
[0279] The "Y" Drive Assembly 5500 is configured to pivot the foot
plate 5344 about the horizontal Y axis, such that a foot captured
by the foot plate causes varus valgus conditions prompted by forces
about a Y-axis of rotation distal to the foot.
[0280] The associated Y drive configuration is different than its
counterpart in the above device 10. The Y drive assembly 5500 is
attached to the underside of lower frame table 5312. It includes an
inline reducer and a torque sensor and drives a vertical shaft 5502
which is captured in two bearings, upper and lower bearings 5505
and 5504, respectively. The upper end of the shaft 5502 is rigidly
attached to the pivoting horizontal foot support plate 5340 via a
flange 5507, such that rotation of the shaft causes rotation of the
foot support plate 5340.
[0281] A shown in FIG. 25, at the front of the pivoting horizontal
foot support plate 5340 is rigidly mounted to a pivoting vertical
foot support flange 5341. Flange 5341 supports the Z axis drive
assembly 5600, such that operation of the Z axis drive assembly
5600 causes rotation of the foot plate 5344 relative to the flange
5341, about the Z axis. As may be understood, this Z axis can be
moved within a horizontal plane, via movement of the "Y" drive
assembly.
[0282] 6. Z Drive Assembly Construction and Operation
[0283] As noted above, the Z axis drive assembly 5600 causes
rotation of the foot plate 5344 relative to the support flange
5341, about the Z axis. When a foot is contained in the foot plate,
this can provide internal and external rotation of the foot and
thus the tibia.
[0284] 7. More Discussion of Decoupling; Different Movements
Possible
[0285] One drive is "decoupled" from the other if motion by the
first drive does not change the position of the second drive in any
direction. However, coupling of drive A to drive B does not imply
coupling of drive B to drive A. Similarly, decoupling of drive A
relative to drive B does not imply decoupling of drive B relative
to drive A.
[0286] This concept extends to multiple drives such that a system
can be configured to have a complex chain of drives working both
dependently and/or independently to influence motion of one limb
segment with respect to another limb segment. In a global sense,
system A of drives could influence the system B of drives but not
vice versa.
[0287] A first drive is coupled to a second drive if motion of the
first drive changes the position of the second drive in any
direction. All drives are `decoupled` when each drive has its own
unique independent influence on the position of the tibia with
respect to the femur. In the first version described above (leg
testing device 10): [0288] The IE Rotation Drive is decoupled from
the AP Drive [0289] Both IE Rotation and AP Drives are coupled
relative to the Valgus Drive (movement of Valgus Drive affects axis
of the other two)
[0290] In the second version described above (leg testing device
5000) [0291] AP Drive is totally decoupled [0292] Valgus Drive
totally decoupled [0293] IE Rotation Drive is coupled relative to
Valgus Drive (movement of Valgus affects axis of IE)
[0294] In device 5000, this allows for the following actions:
[0295] First place patient limb in extreme internal rotation, then
conduct AP test. [0296] First place patient limb in full Valgus as
well as full AP, then do anIErotation test [0297] First push
patient limb posteriorly, then do varus-valgus test [0298] First
put patient limb in extreme varus, then do IErotation test [0299]
First place patient limb in extreme varus and extreme rotation,
then do AP test
[0300] 8. Output Data
[0301] As may be understood, the degrees of the various movements
(Varus-Valgus, AP, IE) can be measured by measuring the movements
of the machines 10, 5000, themselves, by measuring the degrees of
rotation of the drives (by encoding for example) and calibrating as
necessary. The torque encountered during each such movement may
also be measured, suitably calibrated to the limb movement, and
recorded. In the case of the device 10, separate "external"
measurement of the limb of the patient may be detected by
non-invasive systems utilizes sensors or markers that are attached
to the skin, including but not limited to optoelectronic,
ultrasonic, and electromagnetic motion analysis systems. In the
case of the device 5000, separate measurement of the movement of
the limb of the patient may be by using landmarks seen on the
actual bones. There are no markers; one can see the bones in the CT
images.
[0302] 9. Testing for Different Degrees of Leg Flexion
[0303] It may be understood that during the above tests (AP,
varus-valgus, or rotation), there is no flexing of the knee into
flexion or extension. However, as shown in FIGS. 26A and 26B, one
of the present inventions also includes the additional capability
to flex the knee into flexion or extension. This would allow for
similar tests (such as the examples above) done for different
degrees of knee flex.
[0304] 10. Variations
[0305] Note that instead of the two apparatuses 5200 and 5300 being
commonly attached to the lower frame member 5100, they could be
each be attached to a separate frame member such that their
relative positions on the floor could be independently varied.
[0306] The lower frame member 5100 also slides relative to the
floor so the whole machine can go in and out
III. CONCLUSION
[0307] Many modifications and other embodiments of the invention
set forth herein will come to mind to one skilled in the art to
which this invention pertains having the benefit of the teachings
presented in the foregoing descriptions and the associated
drawings.
[0308] Therefore, it is to be understood that the invention is not
to be limited to the specific embodiments disclosed and that
modifications and other embodiments are intended to be included
within the scope of the appended claims. Although specific terms
are employed herein, they are used in a generic and descriptive
sense only and not for purposes of limitation.
[0309] Although distinct embodiments have been described, the
skilled person will understand how features of different
embodiments may be combined.
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